BMS-986453 for Multiple Myeloma

Recruiting at 36 trial locations

Overseen By First line of the email MUST contain the NCT# and Site#

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Juno Therapeutics, Inc., a Bristol-Myers Squibb Company

Disqualifiers: CNS involvement, Plasma cell leukemia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Variable, based on dose-finding

130 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to assess BMS-986453 in participants with relapsed and/or refractory multiple myeloma (RRMM).

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Research Team

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Eligibility Criteria

This trial is for people with multiple myeloma that has come back or didn't respond to treatment. They should have tried at least three prior treatments, including a proteasome inhibitor and an immunomodulatory agent, and seen their disease progress within a year of the last treatment. Good organ function and physical ability (ECOG status 0 or 1) are required.

Inclusion Criteria

I am fully active or restricted in physically strenuous activity but can do light work.

I have had at least 3 treatments for myeloma, including specific types of medication.

My cancer worsened within 12 months after my last myeloma treatment.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive BMS-986453, a dual targeting BCMAxGPRC5D chimeric antigen receptor T cell therapy

Variable, based on dose-finding

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 2 years

Treatment Details

Interventions

• BMS-986453

Trial Overview The study tests BMS-986453 in those with relapsed/refractory multiple myeloma. Participants will also receive Fludarabine and Cyclophosphamide as part of the treatment regimen to evaluate the effectiveness and safety of BMS-986453.

Participant Groups

Group I: Administration of BMS-986453 Experimental Treatment 3 Interventions

Who Is Running the Clinical Trial?

Juno Therapeutics, Inc., a Bristol-Myers Squibb Company

Lead Sponsor

Trials

19

Recruited

3,100+